Widespread 'Off-Label' used medications necessitate extensive research

Chicago, November 24: Drugs, often been approved for certain medical conditions by FDA federal regulations, are being commonly prescribed by doctors at random for other diseases, a new study found out.

This "off-label" prescribing is seen as an unsafe but growing practice amongst doctors. U.S researchers said that antidepressant and antipsychotics drugs are prominently prescribed without referring labels.

They feel that further research is required for 14 drugs found to be used off-label extensively to assess their efficacy and safety factors.

Surrey Walton, lead researcher of the study from University of Illinois at Chicago, said: "Off-label prescribing is not based on the same level of evidence as on-label prescribing." He is an assistant professor of pharmacy administration at the university.

According to Walton, many doctors use a drug for off-label prescriptions for certain conditions that have not been studied by U.S. Food and Drug Administration regulators before approving, thinking that they may benefit the patient. Even the patients don’t have the knowledge about a certain drug finding off-label use while it is approved for some other medical conditions.

"Typically, drugs have to pass a number of safety tests. But once they are put on the market, because they have received approval for an on-label indication, they can be used off-label," said Walton.

The study on off-label prescribing is published in the journal of Pharmacotherapy's November 24 issue.

The foremost is Seroquel, meant to treat schizophrenia under FDA approval is widely used off-label of all medications, seen in almost 76 percent prescriptions. Study authors confirm that despite of FDA's "black box" warning and heavy cost, this drug is sold widely in the market.

The drug manufacturer AstraZeneca appended safety instruction on the drug label in 2004, after FDA intervened about hyperglycemiadefine, high blood pressure and diabetes risks linked with the drug use. FDA warns that old patients on this medication for treatment of dementia-related psychosis are at a greater risk of death.

Some of the frequently and widely used off-label medications are:
- Warfarin - a blood thinning drug which is prescribed off-label for hypertensive heart disease.
- Bupropion (Wellbutrin), Sertraline (Zoloft), Venlafaxine (Effexor), Escitalopram (Lexapro) meant for depressiondefine but used off-label for bipolar disorder.
- Celecoxib (Celebrex) - joint sprain/strain drug used off-label for fibromatosis,
- Lisinopril (Prinivil, Zestril) - high blood pressure medication but used off-label for coronary arterydefine disease,
- Duloxetine (Cymbalta) - for depression but used off-label for anxiety,
- Trazodone (Desyrel) - for depression but used off-label for sleep disorder,
- Olanzapine (Zyprexa) - for schizophrenia, used off-label for depression,
- Epoetin alfa (Procrit, Epogen) – approved for chronic renal failure but used off-label for anemia from chronic disease,
- Risperidone (Risperdal) - for schizophrenia but used off-label as bipolar disorder drug,
- montelukast (Singulair) meant for asthma but prescribed off-label for chronic obstructive pulmonarydefine conditions.

Off-label use of drugs by their manufacturers is prohibited. A previous study indicates that amongst many off-label prescribed drugs in 2001, almost 73 percent had no scientific backing to promote their use off-the-label.

However, off-label use should be continued with constant scrutinization, suggests Walton. He said: "There are certainly clinically sound reasons for some of the off-label use, but more effort should be made to follow-up on these uses. So allow them, but do a better job of tracking them and establishing the evidence."

According to Dr. David Flockhart, director of Division of Clinical Pharmacology at Indiana University School of Medicine, off-label drug use is bound be more widespread because researchers are resorting to individualized-medicine phenomenon, where individualistic genetic profile is studied to prescribe medicines.

"This is the science of the study of average effects -- currently the standard for drug approval and regulation -- running into clinical reality where not every patient experiences exactly the average effect," added Flockhart.